7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FETAL MONITOR, PART #100-11009
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Tranquil Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT
FDA 510(k)
FDA Class 1
·Dental
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 3, 2012
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·September 26, 2013
PFC SIGMARP STB TB IN 6 12.5
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·July 21, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024